Tien Yin Wong1, Yuichiro Ogura2, Won Ki Lee3, Tomohiro Iida4, Shih-Jen Chen5, Paul Mitchell6, Chui Ming Gemmy Cheung7, Zhongqi Zhang8, Sérgio Leal8, Tatsuro Ishibashi9. 1. Singapore Eye Research Institute and Singapore National Eye Centre, Singapore; Duke-National University of Singapore Medical School, National University of Singapore, Singapore. Electronic address: wong.tien.yin@singhealth.com.sg. 2. Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 3. Department of Ophthalmology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea. 4. Department of Ophthalmology, Tokyo Women's Medical University, Tokyo, Japan. 5. Department of Ophthalmology, Taipei Veterans General Hospital and School of Medicine, National Yang-Ming University Taipei, Taiwan. 6. University of Sydney, Sydney, New South Wales, Australia (Westmead Institute for Medical Research). 7. Singapore Eye Research Institute and Singapore National Eye Centre, Singapore; Duke-National University of Singapore Medical School, National University of Singapore, Singapore. 8. Bayer Pharmaceuticals, Berlin, Germany. 9. Department of Ophthalmology, Kyushu University Hospital, Fukuoka, Japan.
Abstract
PURPOSE: We sought to evaluate longer-term efficacy and safety of intravitreal aflibercept monotherapy (IAI) vs IAI plus rescue photodynamic therapy (rPDT) in patients with polypoidal choroidal vasculopathy (PCV). DESIGN: This was a prospective multicenter, double-masked, sham-controlled randomized clinical study across 62 centers. METHODS: In this phase 3b/4 study, patients with PCV with best-corrected visual acuity of 73-24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent) received IAI 2 mg every 4 weeks until week 12, when they were randomized 1:1 to receive IAI or IAI plus rPDT if rescue criteria were met. Patients not requiring rescue received IAI every 8 weeks; those requiring rescue received IAI every 4 weeks plus sham/active PDT. At week 52 (the primary endpoint), IAI was noninferior to IAI plus rPDT. After week 52, treatment intervals could be extended beyond 8 weeks at the investigators' discretion. Noninferiority of IAI vs IAI plus rPDT for mean best-corrected visual acuity change from baseline to week 96 was evaluated. RESULTS: Over 96 weeks, 54 patients (17.0%) met rescue criteria. At week 96, IAI was noninferior to IAI plus rPDT in terms of Early Treatment Diabetic Retinopathy Study letters gained (+10.7 vs +9.1, P = .48). Proportions of patients with complete polyp regression (33.1% vs 29.1%) or without active polyps (82.1% vs 85.6%) were similar. In year 2, the mean number of injections was 4.6 in both arms. No new safety signals were observed. CONCLUSION: IAI monotherapy was noninferior to IAI with rescue PDT up to 96 weeks, and functional and anatomical improvements achieved at 52 weeks were maintained. Few patients required rescue PDT, which provided no additional visual benefit.
RCT Entities:
PURPOSE: We sought to evaluate longer-term efficacy and safety of intravitreal aflibercept monotherapy (IAI) vs IAI plus rescue photodynamic therapy (rPDT) in patients with polypoidal choroidal vasculopathy (PCV). DESIGN: This was a prospective multicenter, double-masked, sham-controlled randomized clinical study across 62 centers. METHODS: In this phase 3b/4 study, patients with PCV with best-corrected visual acuity of 73-24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent) received IAI 2 mg every 4 weeks until week 12, when they were randomized 1:1 to receive IAI or IAI plus rPDT if rescue criteria were met. Patients not requiring rescue received IAI every 8 weeks; those requiring rescue received IAI every 4 weeks plus sham/active PDT. At week 52 (the primary endpoint), IAI was noninferior to IAI plus rPDT. After week 52, treatment intervals could be extended beyond 8 weeks at the investigators' discretion. Noninferiority of IAI vs IAI plus rPDT for mean best-corrected visual acuity change from baseline to week 96 was evaluated. RESULTS: Over 96 weeks, 54 patients (17.0%) met rescue criteria. At week 96, IAI was noninferior to IAI plus rPDT in terms of Early Treatment Diabetic Retinopathy Study letters gained (+10.7 vs +9.1, P = .48). Proportions of patients with complete polyp regression (33.1% vs 29.1%) or without active polyps (82.1% vs 85.6%) were similar. In year 2, the mean number of injections was 4.6 in both arms. No new safety signals were observed. CONCLUSION: IAI monotherapy was noninferior to IAI with rescue PDT up to 96 weeks, and functional and anatomical improvements achieved at 52 weeks were maintained. Few patients required rescue PDT, which provided no additional visual benefit.
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